YY/T 1192-2011Human chorionic gonadotropin(HCG) quantitative detection reagent(kit)(chemiluminescent immunoassay) (English PDF)
人绒毛膜促性腺激素(HCG)定量测定试剂盒（化学发光免疫分析法）
This is a limited preview
Buy now to download the full PDF (19 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1192-2011 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 1192-2011 is the English-translated version of 人绒毛膜促性腺激素(HCG)定量测定试剂盒（化学发光免疫分析法）.
YY/T 1192-2011 is the Chinese pharmaceutical industry standard for the kit that measures human chorionic gonadotropin (HCG) quantitatively by chemiluminescent immunoassay.
It sets the classification of the products, the technical requirements, the test methods and the rules for marks, labels, instructions, packaging, transport and storage, with traceability of the assigned values following GB/T 21415.
It applies to kits that measure HCG in human blood or other body fluids, whether the chemiluminescence is enzymatic or non-enzymatic and whether the carrier is a microplate, a tube, magnetic particles, microbeads or plastic beads.
It does not apply to HCG calibrators and controls sold on their own, nor to biochips based on chemiluminescence. Issued on 31 December 2011, it has applied since 1 June 2013.
Found what you need?
Document preview — YY/T 1192-2011
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Classification4
- 4 Technical requirements5
- 5 Test methods6
- 6 Marks, labels and instructions9
- 7 Packaging, transportation and storage11
- Bibliography12
Foreword
This standard was drafted in accordance with the rules specified in GB/T 1.1-2009.
1 Scope
This standard specifies the classification, requirements, test method, marks, labels, instructions, packaging, transportation and storage etc. of the human chorionic gonadotropin quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to the quantitative detection of human chorionic gonadotropin (HCG) reagent (kit) [hereinafter referred as "HCG reagent (kit)"] of the human blood matrix or other body fluid components, based on the principle of chemiluminescent immunoassay.
It includes the enzymatic and non-enzymatic chemiluminescent immunoassay detection reagent (kit) in the carrier of microplates, pipes, magnetic particles, microbeads and plastic beads. This standard does not apply to.
a) The calibrators and quality-control materials of human chorionic gonadotropin that are intended for separate sale;
b) The biochip that uses chemiluminescent immunoassayas the principle.
2 Normative references
The articles contained in the following documents have become part of this document when they are quoted herein. For the dated documents so quoted, all the modifications (Including all corrections) or revisions made thereafter shall be applicable to this document.
GB/T 21415-2008 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
3 Classification
HCG reagent (kit) can be divided into enzymatic and non-enzymatic chemiluminescent immunoassay reagents (kits) according to different principle of chemiluminescence.
According to different solid-phase carriers, it can be divided into the chemiluminescent
a) Product names and packaging specifications;
b) Name, address, contact information of manufacturers or after-sales service organization;
c) Medical device registration certificate number;
d) Product standard number;
e) Product batch number;
f) Expiration date; g) Storage conditions.
6.2 Marks and labels of each component package of reagent (kit)
It shall contain at least the following contents.
a) Product name and packaging specifications;
b) Name or trademarks of the manufacturers;
c) Product batch number;
d) Expiration date; e) Storage conditions.
6.3 Instructions of reagent (kit)
It shall contain at least the following contents.
a) Product name;
b) Packaging specifications;
c) Intended use;
d) Detection principle;
e) Main compositions;
f) Storage conditions and expiration date;
g) Applicable instrument;
h) Sample requirement;
i) Detection method;
j) Reference value (Reference range);
k) Explanation of the detection result;
l) The limitations of detection methods;
m) Product performance index.
n) Instructions for analytical interference (hemolysis, lipemia, jaundice, etc.);
o) Instructions for specificity analysis (cross-reactants);
p) Precautions;
q) References;
r) Name, address, contact information of manufacturers or after-sales service organization;
s) License number of medical device manufacturing enterprise (limited to domestic enterprises);
t) Medical device registration certificate number;
u) Product standard number;
v) Approval and modified date of instructions.
7 Packaging, transportation and storage
7.1 Package
Reagent (kit) shall be packaged according to the requirements of the manufacturing enterprise.
7.2 Transportation
Reagent (kit) shall be transported according to the requirements of the manufacturing enterprise.
7.3 Storage
Reagent (kit) shall be stored under the conditions specified by the manufacturing enterprise.
Bibliography 1. YY/T 0316-2008 Medical devices - Application of risk management to medical devices (ISO 14971. 2007, IDT)
2. YY/T 0466.1-2009 Devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223.1-2009, IDT)
3 GB/T 191-2008 Packaging - Pictorial marking for handling of goods
4. GB/T 9969-2008 General principles for preparation of instructions for use of industrial products
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 1192-2011
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
YY/T 0479-2026 — Medical diagnostic X-ray tube assemblies and X-ray source assemblies - Determination of maximum symmetric radiation field
Secure payment via Stripe
Payments accepted
YY/T 1192-2011
$125.00